Completed

NCT Number: NCT00002436

The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT

To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination with AZT.

PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.

Completed

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Key information

Conditions

HIV Infections AIDS-Related Complex Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ottawa General Hospital, Ottawa, Ontario, Canada

About this study

Patients are randomized to one of three treatment arms: low-dose 3TC plus AZT, high-dose 3TC plus AZT, or ddC plus AZT. Treatment continues for 32 weeks, with possible extension to 52 weeks.

PER 02/27/95 AMENDMENT: Patients may continue therapy on AZT and low-dose 3TC on an open-label basis. Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must have:

HIV positivity.
CD4 count 100-300 cells/mm3.
Prior AZT therapy for 24 or more weeks and currently on AZT.

Exclusion criteria

Patients with the following prior conditions are excluded:

History of intolerance to AZT.
History of grade 2 or worse peripheral neuropathy.

Prior Medication:

Excluded:

Any prior antiretroviral therapy other than AZT.

Required:

Concomitant AZT therapy.

Required:

At least 24 weeks of prior AZT.

Treatment and study plan

Lamivudine

Drug

Zidovudine

Drug

Zalcitabine

Drug

Sponsors and collaborators

Lead sponsor

Glaxo Wellcome

Industry

Registry information

Official study title

A Randomized Lamivudine (3TC)/Dideoxycytidine (ddC) Double-Blind Multicenter Trial (With Open-Label AZT) to Evaluate the Safety and Efficacy of Low Dose 3TC Administered Concurrently With AZT Versus High Dose 3TC Administered Concurrently With AZT Versus ddC Administered Concurrently With AZT in the Treatment of HIV-1 Infected, AZT-Experienced (>= 24 Weeks) Patients With CD4 Counts of 100-300 Cells/mm3

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed